Device Classification Name |
Wheelchair, Powered
|
510(k) Number |
K011993 |
Device Name |
QUANTUM BLAST |
Applicant |
PRIDE MOBILITY PRODUCTS CORP. |
182 SUSQUEHANNA AVE. |
EXETER,
PA
18643
|
|
Applicant Contact |
GENE R KULON |
Correspondent |
PRIDE MOBILITY PRODUCTS CORP. |
182 SUSQUEHANNA AVE. |
EXETER,
PA
18643
|
|
Correspondent Contact |
GENE R KULON |
Regulation Number | 890.3860
|
Classification Product Code |
|
Date Received | 06/26/2001 |
Decision Date | 07/13/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|